PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery

Conditions

• Homonymous Hemianopsia
• Homonymous Quadrantanopia

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display — DEVICE
  PAVE (Parallactic Visual-Field Enhancement) treatment is visual stimulation using a virtual reality head mounted display. The treatment is three times per week and entails two 7 minute sessions separated by a minimum 1 minute intermission. The actual therapy is preceded by a visual field assessment and is followed by a second visual field assessment.

Study Details

This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, or brain surgery. The PAVE regimen involves the use of a virtual reality headset to deliver visual stimulation to subjects diagnosed with visual field loss. The primary objective is to demonstrate that there is an improvement in the visual field after use of the PAVE therapy over a period of eight weeks with three sessions per week. The primary outcome is an increase in visual field area as measured with Goldmann-type kinetic perimetry. The secondary outcome will be demonstration that the subjective assessment of visual function using the National Eye Institute Visual Function Questionnaire (NEI-VFQ) is better after PAVE therapy when compared to before therapy. The participants will visit the investigators office at the start of the study to establish a baseline for visual field size and visual field function. The subject will use PAVE in the office or at home three times per week for eight weeks. There will be twenty four therapy sessions in total. At four weeks the subject will visit the office and have perimetry measurements. At eight weeks the subject will visit the office and have perimetry measurements and complete the NEI-VFQ survey. Four weeks after the completion of the therapy sessions a follow up visit will take place where visual field measurement using kinetic perimetry and NEI-VFQ will be administered.

Key Dates

Start date

Mar 16, 2026

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Test
  Treatment using actual PAVE therapy software operating on a virtual reality head mounted display three times per week for eight weeks.

Primary Outcome Measure

Population Mean Change in Visual Field Area [ Time Frame: Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12. ]

Central Contacts

• Michael Lynch, BSME
  315-730-9842
  [email protected]
• Paige Clinical Study Coordinator
  319-366-3500
  [email protected]

Locations (2)

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